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510(k) K964946

SYSMEX CA-1000/SYSMEX CA-5000 by Sysmex Corp. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1997
Date Received
December 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Sysmex Corp.

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  • K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (November 3, 1998)
  • K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER (August 14, 1998)
  • K971736 — SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER (August 26, 1997)
  • K964375 — SYSMEX SE/RAM-1 (March 13, 1997)
  • K961054 — SYSMEX UF-100 (October 28, 1996)
  • K950508 — SYSMEX SF-3000 (November 3, 1995)
  • K945837 — SYSMEX(TM) F-820, 520 (June 9, 1995)
  • K942097 — TOA MEDICAL ELECTRONICS CA-5000 (March 24, 1995)

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